A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of INCB001158 in Combination With Chemotherapy, in Subjects With Advanced or Metastatic Solid Tumors

A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors

Sponsors

Lead sponsor: Incyte Corporation

Source Incyte Corporation
Brief Summary

The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.

Overall Status Recruiting
Start Date November 20, 2017
Completion Date October 6, 2021
Primary Completion Date October 6, 2021
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Phase 1: Participants with treatment-emergent adverse events (TEAE) 28 days
Phase 2: Objective response rate Every 8 weeks for duration of study participation which is estimated to be 18 months.
Secondary Outcome
Measure Time Frame
Phase 2: Participants with TEAEs Screening through 90 days after end of treatment, up to 21 months.
Phase 1: Objective response rate Every 8 weeks for duration of study participation, up to 18 months.
Duration of response Every 8 weeks for duration of study participation, up to 18 months.
Disease control rate Every 8 weeks for duration of study participation, up to 18 months.
Progression-free survival Every 8 weeks for duration of study participation, up to 18 months
Enrollment 249
Condition
Intervention

Intervention type: Drug

Intervention name: INCB001158

Description: Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.

Other name: Arginase inhibitor

Intervention type: Drug

Intervention name: Oxaliplatin

Description: Oxaliplatin administered intravenously at the protocol-defined dose and schedule.

Arm group label: Treatment Group A

Intervention type: Drug

Intervention name: Leucovorin

Description: Leucovorin at the protocol-defined dose and regimen.

Arm group label: Treatment Group A

Intervention type: Drug

Intervention name: 5-Fluorouracil

Description: 5-Fluorouracil at the protocol-defined dose and regimen.

Arm group label: Treatment Group A

Intervention type: Drug

Intervention name: Gemcitabine

Description: Gemcitabine at the protocol-defined dose and regimen.

Arm group label: Treatment Group B

Intervention type: Drug

Intervention name: Cisplatin

Description: Cisplatin at the protocol-defined dose and regimen.

Arm group label: Treatment Group B

Intervention type: Drug

Intervention name: Paclitaxel

Description: Paclitaxel at the protocol-defined dose and regimen.

Arm group label: Treatment Group C

Eligibility

Criteria:

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.

- Presence of measurable disease per RECIST v1.1.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen.

- Resolution of treatment-related toxicities.

- Adequate hepatic, renal, cardiac, and hematologic function.

- Additional cohort-specific criteria may apply.

Exclusion Criteria:

- Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose.

- Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.

- Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.

- Has received prior approved radiotherapy within 14 days of study therapy.

- Has had known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.

- Has an active autoimmune disease that has required systemic treatment in past 2 years.

- Has an active infection requiring systemic therapy.

- Has known active CNS metastases and/or carcinomatous meningitis.

- Women who are pregnant or breastfeeding.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Sven Gogov, MD Study Director Incyte Corporation
Overall Contact

Last name: Incyte Corporation Call Center (US)

Phone: 1.855.463.3463

Email: [email protected]

Location
facility status
University of Alabama | Birmingham, Alabama, 35294-3300, United States Recruiting
USA Mitchell Cancer Center | Mobile, Alabama, 36604, United States Recruiting
UC Davis - Comprehensive Cancer Centre | Sacramento, California, 95817, United States Recruiting
Northwest Georgia Oncology Centers | Marietta, Georgia, 30060, United States Recruiting
The University of Texas MD Anderson Cancer Center | Houston, Texas, 77030, United States Recruiting
START San Antonio | San Antonio, Texas, 78229, United States Recruiting
Grand Hopital de Charleroi - Department of Medical Oncology | Brussels, 6000, Belgium Recruiting
Institut Jules Bordet - Clinical Trials Conduct Unit | Brussels, B-1000, Belgium Recruiting
UCL Cancer Institute | London, WC1E 6BT, United Kingdom Recruiting
The Christie NHS Foundation Trust | Manchester, M20 4BX, United Kingdom Recruiting
Location Countries

Belgium

United Kingdom

United States

Verification Date

April 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Treatment Group A

Arm group type: Experimental

Description: INCB001158 + FOLFOX

Arm group label: Treatment Group B

Arm group type: Experimental

Description: INCB001158 + gemcitabine/cisplatin

Arm group label: Treatment Group C

Arm group type: Experimental

Description: INCB001158 + paclitaxel

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov